Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

Approval Order StatementAPPROVAL FOR COAPTITE. THE DEVICE IS INDICATED FOR SOFT TISSUE AUGMENTATION IN THE TREATMENT OF STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD) IN ADULT FEMALES.